Pharmaceutical company GlaxoSmithKline will pay $1,579,490 to Iowa’s consumer education and litigation fund as part of a multi-state settlement stemming from its marketing of its diabetes drug Avandia.
Iowa Attorney General Tom Miller and 37 other attorneys general alleged that GSK engaged in unfair and deceptive practices by misrepresenting Avandia’s cardiovascular risks and safety profile.
GSK pleaded guilty July 5 to failing to provide required clinical data in its annual report to the U.S. Food & Drug Administration (FDA) on Avandia’s cardiovascular safety. The company also admitted to illegally promoting the anti-depressant drug Paxil with false and misleading statements about the safety of the drug for use in children, and illegal off-label promotion of the anti-depressant drug Wellbutrin for weight loss, sexual function, and other uses for which it was not approved.
U.S. District Court Judge Rya W. Zobel ordered GSK to pay $1 billion in connection with the criminal case. GSK also agreed to pay an additional $2 billion in restitution to the federal health care programs together with other civil payments.
Last November, the FDA heavily restricted access to the drug by announcing that health care providers must enroll in a federal program if they wish to prescribe rosiglitazone medicines to outpatients or patients in long-term care facilities. The restrictions were in response to data that suggested an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
As part of the agreement, GSK agreed to reform how it markets and promotes diabetes drugs.